Inspiris Resilia Aortic Valve
FDA premarket approval P150048/S003 · decided 2018-01-08
Approval details
- PMA number
- P150048
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- Inspiris Resilia Aortic Valve
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Edwards Lifesciences, LLC
- Date received
- 2017-08-08
- Decision date
- 2018-01-08
- Days to decision
- 153 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for protocol for the post-approval study (PAS) protocol. The PAS protocol (Version A:) for the OSB Lead-Model 11500A Prospective PAS.
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